The effect of body composition on infliximab (remicade/inflectra) on inflamamtory bowel disease (Crohn's disease, Colitis Ulcerosa)
Recruiting
- Conditions
- Inflammatory bowel disease,Crohn's diseaseColitis Ulcerosa
- Registration Number
- NL-OMON28109
- Lead Sponsor
- Zuyderland Medisch CentrumAfdeling MDL en Klinische farmacologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 33
Inclusion Criteria
Patiënt are eligible to participate in the study if all of the following criteria are met:
1. Patient, male or female, is aged above 18 years
Exclusion Criteria
Patients are not eligible if one or more of the following criteria are met:
1. Patient is mentally or physically not able to participate to the study, including severe mental illness.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure is the correlation between fat mass, measured by an validated body composition monitor(BCM), and the IFX level. This will be measured prior to the IFX infusion. The IFX concentration will be measured and analysed in blood. Prior to de IFX infusion the trough level will be measured (according to regular health care). 30 minutes after the end of the infusion the top level will be measured.
- Secondary Outcome Measures
Name Time Method Secondarily, the body composition(skinfold thickness, waist circumference, hand grip strength), BMI and body surface will be correlated to the IFX concentration. Furthermore, the disease activity, inflammation parameters and the amount of adverse effects will be measured en correlated to the fat mass.